Dr. Carrigan has over 20 years of experience in observational studies with a focus on study design and methodology. He is experienced with the use of electronic medical records (EMR), administrative claims data, and registry data. He has worked with observational data in a number of settings and therapeutic areas including oncology, neuroscience, respiratory disease, and vaccine safety. In recent years, he has focused on applying epidemiological methods to real-world oncology data to augment evidence from clinical trials.

Nancy Dreyer served as Chief Scientific Officer at IQVIA Real World Solutions, Global Chief of Scientific Affairs at Outcome Sciences Inc and Quintiles, and CEO of Epidemiology Resources Inc. prior to switching to consultancy. She maintains active practice in the biopharmaceutical industry. Her primary research interest is to advance use of RWE including patient-generated health data, electronic medical records, medical and pharmacy claims, data linkage and data integration for studies of safety, effectiveness and natural history. She is a Fellow of ISPE, a Science and Policy Advisor and Fellow of DIA, Adjunct Professor of Epidemiology at the Univ of North Carolina at Chapel Hill and serves on ISPOR's RWE Leadership Team.

Brian D. Bradbury is Vice President and Head of the Center for Observational Research (CfOR) at Amgen, Inc. He leads a global team of epidemiologists, data scientists, programmers and operations professionals who generate real-world evidence (RWE) to support the development and continuous benefit:risk assessment of Amgen's medicines. Brian also holds an Adjunct Professor of Epidemiology appointment at the University of California, Los Angeles. He received his DSc in Epidemiology from Boston University and a MA in Education and Psychology from Pepperdine University. He has authored/co-authored 90+ peer-reviewed publications in the areas of pharmacoepidemiology, cancer, kidney, cardiovascular and bone disease.

Dr. Reynolds is a member of the Center for Advanced Evidence Generation, Real World Solutions at IQVIA. He designs innovative solutions for real world evidence on effectiveness and safety. Dr. Reynolds brings more than 20 years of diverse experience in non-interventional research and has a deep expertise in the usage of real world data to address questions of effectiveness, safety, and value of pharmaceutical products. He founded and led the successful Database Special Interest Group for the International Society of Pharmacoepidemiology where he served as an elected executive leader. Dr. Reynolds earned his graduate and doctoral degrees in epidemiology and preventive medicine from the University of Maryland at Baltimore in January 2000.